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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coil, Magnetic Resonance, Specialty
510(k) Number K010802
Device Name CARDIAC VIEW, MODEL 2001
Applicant
Magna Lab, Inc.
150 California St.
Newton,  MA  02458
Applicant Contact LYNN CARTER
Correspondent
Magna Lab, Inc.
150 California St.
Newton,  MA  02458
Correspondent Contact LYNN CARTER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received03/16/2001
Decision Date 06/08/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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